Manhattan Pharmaceuticals Announces License Agreement and Expanded Pipeline
April 04 2007 - 9:29AM
PR Newswire (US)
Company Acquires Two New Clinical-Stage Drug Candidates NEW YORK,
APRIL 4 /PRNewswire-FirstCall/ -- Manhattan Pharmaceuticals, Inc.
(AMEX:MHA) today announced that it has acquired exclusive, North
American rights to develop and commercialize two novel product
candidates from Thornton & Ross Limited - the largest
independent pharmaceutical manufacturer in the United Kingdom (UK).
The two acquired product candidates are Altoderm(TM) (topical
cromolyn sodium) for the treatment of atopic dermatitis and
Altolyn(TM) (oral cromolyn sodium tablet) for the treatment of
mastocytosis. The company believes the acquisition of these two
product candidates is an important step in the Manhattan
Pharmaceuticals corporate strategy as it allows the company to
continue to create a robust pipeline while building on the existing
dermatology franchise. Cromolyn sodium, also known as sodium
cromoglycate, is a non-steroidal, anti-inflammatory medicine that
has been used worldwide for over 35 years to treat a number of
allergic conditions including asthma, allergic rhinitis (nasal
allergies), allergic conjunctivitis, and mastocytosis. Altoderm(TM)
is a novel, proprietary formulation of topical cromolyn sodium and
is designed to enhance the absorption of cromolyn sodium in order
to treat atopic dermatitis, or "eczema". This product candidate is
currently being tested in a Phase 3 clinical trial in the UK. In a
previously completed randomized, double-blind, placebo-controlled,
parallel-group, Phase 3 clinical study the compound was
administered for 12 weeks to 144 child subjects with moderately
severe atopic dermatitis. In the study results, published in the
British Journal of Dermatology in February 2005, Altoderm(TM)
demonstrated a statistically significant reduction in symptoms.
During the study, subjects were permitted to continue with their
existing treatment, in most cases this consisted of emollients and
topical steroids. A positive secondary outcome of the study was a
reduction in the use of topical steroids for the Altoderm(TM)-
treated subjects. According to the National Institutes of Health
(NIH), more than 15 million people in the US have symptoms of
atopic dermatitis, and US health insurance companies spend more
than $1 billion per year on the condition. Altolyn(TM) is a
proprietary, site specific, tablet formulation of oral cromolyn
sodium for the treatment of mastocytosis. This novel formulation is
designed to provide optimal availability by preferentially
releasing the drug in the upper part of the small intestine, the
purported site of action. Early clinical experience in the UK
suggests promising activity in patients with various allergic
disorders, including inflammatory bowel conditions. Oral cromolyn
sodium is the active ingredient in Gastrocrom(R) an oral liquid
solution that is currently FDA approved for the treatment of
mastocytosis. "Altoderm(TM) and Altolyn(TM) are innovative topical
and oral formulations of cromolyn sodium, a widely used molecule
with a well established safety profile. We believe Altoderm(TM) has
the potential to provide an important treatment alternative to
steroids and immunomodulators for patients with atopic dermatitis,"
stated Doug Abel, President and Chief Executive Officer. "Our new
relationship with Thornton & Ross Limited represents an ideal
strategic opportunity for Manhattan Pharmaceuticals. Thortnon &
Ross is an industry leader for prescription and consumer products
in the UK, with a pipeline of innovative healthcare products. The
addition of these two product candidates is an important step in
our corporate strategy as it allows us to grow our existing
dermatology business, while continuing to build a strong, diverse
pipeline." This licensing transaction increases the Manhattan
Pharmaceuticals pipeline to five clinical stage product candidates.
About Atopic Dermatitis According to the NIH, more than 15 million
people in the U.S. have symptoms of atopic dermatitis with an
estimated 20 percent of those being infants and young children.
Roughly 60 percent of these infants continue to have one or more
symptoms in adulthood. It affects both males and females and
accounts for 10 to 20 percent of all visits to dermatologists.
Atopic dermatitis is a chronic (long-lasting) disease that affects
the skin. It is not contagious; it cannot be passed from one person
to another. In atopic dermatitis, the skin becomes extremely itchy.
Scratching leads to redness, swelling, cracking, "weeping" clear
fluid, and finally, crusting and scaling. The cause of atopic
dermatitis is not known, but the disease seems to result from a
combination of genetic (hereditary) and environmental factors. The
most common symptoms are dry, itchy skin and rashes on the face,
inside the elbows and behind the knees, and on the hands and feet.
Currently, topical corticosteroids are the primary
anti-inflammatory treatment for atopic dermatitis. They are
extremely effective in controlling acute exacerbations, and are
also used for long-term maintenance treatment when emollients alone
do not provide adequate control. However, local side effects are
common, in particular skin thinning, telangiectasis, bruising,
hypopigmentation, acne, striae and secondary infection. There is,
therefore, an understandable reluctance on the part of patients,
parents and physicians to use topical corticosteroids on a
long-term basis. Recently, topical formulations of the
immunosuppressive drugs tacrolimus and pimecrolimus have been
introduced as anti-inflammatory agents. However, there is limited
evidence of their long-term safety. About Mastocytosis Mastocytosis
is a rare disorder that occurs in both children and adults. It is
caused by the presence of too many mast cells in the body. Mast
cells are found in skin, linings of the stomach and intestine, and
connective tissue (such as cartilage and tendons). Mast cells play
an important role in helping the immune systems defend these
tissues from disease. They release chemical "alarms" such as
histamine and cytokines to attract other key players of the immune
defense system to sites in the body where they might be needed.
People with mastocytosis experience abdominal discomfort, nausea
and vomiting, ulcers, diarrhea, and skin lesions. About Manhattan
Pharmaceuticals, Inc. Manhattan Pharmaceuticals, Inc., a
development-stage pharmaceutical company, acquires and develops
proprietary prescription drugs for large, underserved patient
populations. In view of the worldwide obesity epidemic, the company
is developing OE, an orally administered novel therapeutic for the
treatment of both common obesity and morbid obesity. To meet the
needs of other major, underserved medical markets Manhattan
Pharmaceuticals is also developing PTH (1-34), a peptide believed
to be a regulator of epidermal cell growth, for the treatment of
psoriasis, and Propofol Lingual Spray, a convenient, proprietary
lingual spray formulation of propofol, the world's best-selling
general anesthetic, as a sedative-hypnotic for use during
diagnostic and therapeutic procedures.
(http://www.manhattanpharma.com/) About Thornton & Ross Limited
Founded in Huddersfield, Thornton & Ross (T&R) is a
privately-owned company which has grown to become a significant
player within the UK healthcare market with brands which span the
Rx, OTC and consumer sectors. Its leading brands include COVONIA
(cough cold and flu range), HEDRIN (Headlice treatment), CARE
(range of everyday medicines), ALGESAL and TRANSVASIN (topical
analgesics), SETLERS and GASTROCOTE (heartburn and indigestion
remedies). T&R's leading household brand is ZOFLORA a range of
floral disinfectants. T&R manufactures the majority of its
products, specializing in pharmaceutical liquids and creams. The
company employs 350 people and has a turnover approaching 40
million pounds Sterling. (http://www.thorntonross.com/) Note
Regarding Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements involve
risks and uncertainties that could cause Manhattan Pharmaceutical's
actual results to differ materially from the anticipated results
and expectations expressed in these forward-looking statements.
These statements are often, but not always, made through the use of
words or phrases such as "anticipates," "expects," "plans,"
"believes," "intends," and similar words or phrases. These
statements are based on current expectations, forecasts and
assumptions that are subject to risks and uncertainties, which
could cause actual outcomes and results to differ materially from
these statements. Among other things, there can be no assurances
that any of Manhattan's development efforts relating to
Altoderm(TM) or Altolyn(TM) or any of its other product candidates
will be successful. Other risks that may affect forward-looking
information contained in this press release include the possibility
of being unable to obtain regulatory approval of Manhattan's
product candidates, including Altoderm(TM) or Altolyn(TM), the risk
that the results of clinical trials may not support Manhattan's
claims, Manhattan's reliance on third-party researchers to develop
its product candidates, and its lack of experience in developing
and commercializing pharmaceutical products. Additional risks are
described in the company's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-KSB for the year
ended December 31, 2006. Manhattan assumes no obligation to update
these statements, except as required by law. DATASOURCE: Manhattan
Pharmaceuticals, Inc. CONTACT: Michael G. McGuinness, Chief
Financial Officer, Manhattan Pharmaceuticals, Inc.,
+1-212-582-3950; or Dieno George, Chief Executive Officer, Thornton
& Ross Limited, +44 (01484) 842217, ; or Thomas Redington,
Redington, Inc. +1-203-222-7399, +1-212-926-1733 Web site:
http://www.thorntonross.com/ http://www.manhattanpharma.com/
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